EDITORIAL S I N O - A M E R I C A N C O L L A B O R AT I O N Tim Z. Shi, Hong Liang, and Xiaokun Liang are the Executive Director, Project Manager, and Educator, respectively, at the GlobalMD Organization, Beijing Ofce, Beijing, China.
Qimin Zhan is Vice President and Professor at the Chinese Academy of Medical Sciences, State Key Laboratory of Molecular Oncology Cancer Institute, Cancer Hospital Peking Union Medical College, Beijing, China.
Barbara M. Alving is Professor at University of Maryland, School of Public Health, College Park, Maryland, USA.
Depei Liu is Professor at Chinese Academy of Medical Sciences, Institute of Basic Medical Sciences, Beijing, China. Jianping Dai is Vice Chairman of the Chinese Medical Association and Professor at Beijing Capital Medical University, Beijing Tiantan Hospital, Beijing, China. Anantha Shekhar is Senior Vice Dean at University of Indiana, Institute of Clinical and Translational Sciences, Indianapolis, IN, USA. Xiaobing Fu is Director and Professor at Chinese PLA General Hospital, Institute of Basic Medical Sciences, Beijing, China. Corresponding author. E-mail: fuxiaobing@ vip.sina.com Citation: T. Z. Shi, H. Liang, X. Liang, Q. Zhan, K. Dai, B. M. Alving, D. Liu, J. Dai, A. Shekhar, X. Fu, Joining forces to drive biomedical translation. Sci. Transl. Med. 7, 275ed1 (2015). 10.1126/scitranslmed.aaa2363
INITIATED IN 2009, THE SINOAMERICAN SYMPOSIUM ON CLINICAL AND TRANSLA tional Medicine is now in its 5th year and has laid a strong foundation for productive partnerships. Participants now come from more than 30 U.S. academic institutions that have received U.S. National Institutes of Health (NIH) Clinical and Translational Science Awards (CTSAs) and more than 100 Chinese clinical and translational centers. As a gathering of diverse stakeholders, the symposia have provided a forum for developing a vision and a network to carry out the mission of clinical and translational science among the biomedical research and health care communities of the United States, China, and other countries. Goals include the implementation of cross-cultural education and training programs, development of networks for organizing patient-oriented consortia, creation of platforms for defning specifc health care problems to be solved, cultivation of resources for sharing collaboration tools, and wide adoption of best practices regarding human research protections, biobanks, and ethical translational research. Implementation of these goals should result in better outcomes for patients around the world.
Downloaded from http://stm.sciencemag.org/ on November 14, 2015
Kerong Dai is Director and Professor at Bone and Joint Research Center, Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Joining forces to drive biomedical translation
KEY AREAS FOR FUTURE FOCUS Te scientifc advisory committee of the Sino-American symposium comprises translational research experts and executive members who share common interests in promoting international partnerships. Committee members are well represented across U.S. and Chinese academic institutions, teaching hospitals, regulatory agencies, nonproft organizations, and industry. To nurture further fruitful collaborations between the U.S. and Chinese translational science communities, the scientifc advisory committee has drafed a new 5-year strategic plan (for 2014 to 2019) and is eager to share it publicly and invite comment from the scientifc and policy communities in both countries. As the recent Institute of Medicine report on the CTSA program noted (1), community engagement is a fundamental pillar for creating a full spectrum of translational research activities, and this area needs further exploration in the context of our international platform. Highlights of the draf strategic plan are summarized in the following sections. Education and training programs. For implementation of education and training programs, the primary driving forces and leadership organizations are the Association for Clinical and Translational Science, the CTSA consortium of education and training programs in the United States, and the Chinese Medical Association and Chinese International Medical Exchange Foundation in China. For establishing unifed scientifc disciplines and quality standards in translational research, a measurable and executable goal is to develop shared curricula and to catalog expertise in training and education. Because of the vastly diferent clinical, therapeutic, and medical education environments across the two countries, best practices for training include problem-based study strategies—for example, in the United States, focusing on translation of discoveries and better patient outcomes from bench to the bedside, while in China focusing on challenges of moving therapeutic questions back to the laboratory for further research. A prime solution for disseminating advanced knowledge and informatics would be to develop online courses, smart phone–based applications, and focus-group webinars that provide active platforms for engaging new generations of physician-scientists. Te long-term goal for education and training collaborations is to enable U.S. and Chinese universities and health institutes to pursue joint education programs for advanced degrees in clinical and translational science. Collaboration models for research projects. In current models of collaboration and communication in health care–related translational research, the key stakeholder communities are academia, industry, and regulators. Te goal is to reduce the barriers in communications across these three groups and to share visions and expertise among the investigators and decision-makers from each of the groups. In the draf strategic plan to guide Sino-American collaboration, we propose an “NPR” model—that is, one of integrated networks, platforms, www.ScienceTranslationalMedicine.org 18 February 2015 Vol 7 Issue 275 275ed1
1
EDITORIAL
Downloaded from http://stm.sciencemag.org/ on November 14, 2015
and resources—to facilitate interactions among national and international scientifc communities. To determine how the NPR model can beneft specifc collaborations, each party’s interests and priorities must be fairly and clearly delineated. Terefore, the plan needs networks to efectively organize patient-oriented consortia and focus groups. Such a concept also needs platforms to clearly defne specifc interests in human diseases and problems to be resolved. It also needs resources for sharing innovative tools and solutions to enable high-quality collaborative work, to validate the efectiveness and efciency of collaboration products, and to facilitate community engagement across countries. Science frst: Sharing standards and best practices. To promote “science frst” as a guiding principle for translational research collaborations, all parties must adopt best practices—for example, regarding biobanks, such as the guidelines prepared by the International Society for Biological and Environmental Repositories (2)—and establish a joint biobank-qualitymanagement accreditation program. All parties must also discuss the critical path from discovering biomarkers to regulatory reviewing standards as described by the Biomarker Qualifcation Program (www.fda.gov/drugs/developmentapprovalprocess/drugdevelopmenttoolsqualifcationprogram/ucm284076.htm), which was developed jointly by the U.S. Food and Drug Administration and other international regulatory agencies. Te strategic plan also asks for the development and implementation of best-practice models for addressing needs in bioinformatics, intellectual property rights, and technology transfer agreements across international borders. Regulatory science, bioethics, and research-participant protections. Te draf strategic plan also addresses the shared responsibilities to harmonize regulatory sciences across both countries and to understand the unique regulatory policies applied by individual countries. Furthermore, in alignment with the trends of globalization in clinical and translational science, it will be necessary to address how to catalyze investigator-initiated translational research as a proof of concept, to fnd ways to advance industry-sponsored translational research as a model for bringing innovations to the market, and to identify efective and effcient solutions to fll in gaps in care delivery to improve health care quality. An accreditation program for human research protection established by the nonproft Association for the Accreditation of Human Research Protection Programs, Inc., has been introduced in Chinese research enterprises and in hospital-based clinical and translational research centers. Tis program could provide templates for developing regional standards and best practices in cooperation with human research protection standards and bioethics guidelines. Tus, building common ethical standards along with translational research practice would be one of the greatest challenges faced by all parties, but it must be completed well in advance of initiating large-scale collaborations. By 2019, we envision that the Sino-American symposium consortia will be maturing as an international clinical and translational science research community under the NPR model. Meanwhile, more internationally oriented physician-scientists will be trained and will have participated in Sino-American collaborations. It is our collective responsibility to formalize human research protection standards to create an improved translational research environment globally and to share scientifc standards and best practices across international borders. Tim Z. Shi, Hong Liang, Xiaokun Liang, Qimin Zhan, Kerong Dai, Barbara M. Alving, Depei Liu, Jianping Dai, Anantha Shekhar, Xiaobing Fu
SUPPLEMENTARY MATERIALS www.sciencetranslationalmedicine.org/cgi/content/full/7/275/275ed1/DC1 Table S1. Bilateral partnerships between the U.S. and Chinese academic institutions to promote clinical and translational sciences.
1. U.S. Institute of Medicine, The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research (National Academies Press, Washington, DC, 2013); www.nap.edu/catalog.php?record_id=18323&utm_expid=44180425.krRTDpXJQISoXLpdo-1Ynw.0. [A Chinese edition, published by Science Press and carrying the ISBN 978-7030408051, is available from www.amazon.com/Translational-Research-Exploration-Medicine-Chinese/dp/7030408055.] 2. International Society for Biological and Environmental Repositories, 2012 best practices for repositories: Collection, storage, retrieval, and distribution of biological materials for research. Biopreserv. Biobank 10, 79–161 (2012). ACKNOWLEDGMENT: We thank K. O’Moore-Klopf (East Setauket, NY, USA) for professional English-language editing of this article.
www.ScienceTranslationalMedicine.org 18 February 2015 Vol 7 Issue 275 275ed1
2
Joining forces to drive biomedical translation Tim Z. Shi, Hong Liang, Xiaokun Liang, Qimin Zhan, Kerong Dai, Barbara M. Alving, Depei Liu, Jianping Dai, Anantha Shekhar and Xiaobing Fu (February 18, 2015) Science Translational Medicine 7 (275), 275ed1. [doi: 10.1126/scitranslmed.aaa2363] Editor's Summary
Article Tools
Visit the online version of this article to access the personalization and article tools: http://stm.sciencemag.org/content/7/275/275ed1
Supplemental Materials
"Supplementary Materials" http://stm.sciencemag.org/content/suppl/2015/02/17/7.275.275ed1.DC1
Related Content
Permissions
The editors suggest related resources on Science's sites: http://stm.sciencemag.org/content/scitransmed/5/196/196ed11.full http://stm.sciencemag.org/content/scitransmed/4/122/122cm3.full http://stm.sciencemag.org/content/scitransmed/6/242/242cm6.full http://stm.sciencemag.org/content/scitransmed/2/52/52cm26.full http://stm.sciencemag.org/content/scitransmed/5/200/200fs35.full http://stm.sciencemag.org/content/scitransmed/7/281/281fs13.full Obtain information about reproducing this article: http://www.sciencemag.org/about/permissions.dtl
Science Translational Medicine (print ISSN 1946-6234; online ISSN 1946-6242) is published weekly, except the last week in December, by the American Association for the Advancement of Science, 1200 New York Avenue, NW, Washington, DC 20005. Copyright 2015 by the American Association for the Advancement of Science; all rights reserved. The title Science Translational Medicine is a registered trademark of AAAS.
Downloaded from http://stm.sciencemag.org/ on November 14, 2015
The following resources related to this article are available online at http://stm.sciencemag.org. This information is current as of November 14, 2015.
Qimin Zhan is Vice President and Professor at the Chinese Academy of Medical Sciences, State Key Laboratory of Molecular Oncology Cancer Institute, Cancer Hospital Peking Union Medical College, Beijing, China.
Barbara M. Alving is Professor at University of Maryland, School of Public Health, College Park, Maryland, USA.
Depei Liu is Professor at Chinese Academy of Medical Sciences, Institute of Basic Medical Sciences, Beijing, China. Jianping Dai is Vice Chairman of the Chinese Medical Association and Professor at Beijing Capital Medical University, Beijing Tiantan Hospital, Beijing, China. Anantha Shekhar is Senior Vice Dean at University of Indiana, Institute of Clinical and Translational Sciences, Indianapolis, IN, USA. Xiaobing Fu is Director and Professor at Chinese PLA General Hospital, Institute of Basic Medical Sciences, Beijing, China. Corresponding author. E-mail: fuxiaobing@ vip.sina.com Citation: T. Z. Shi, H. Liang, X. Liang, Q. Zhan, K. Dai, B. M. Alving, D. Liu, J. Dai, A. Shekhar, X. Fu, Joining forces to drive biomedical translation. Sci. Transl. Med. 7, 275ed1 (2015). 10.1126/scitranslmed.aaa2363
INITIATED IN 2009, THE SINOAMERICAN SYMPOSIUM ON CLINICAL AND TRANSLA tional Medicine is now in its 5th year and has laid a strong foundation for productive partnerships. Participants now come from more than 30 U.S. academic institutions that have received U.S. National Institutes of Health (NIH) Clinical and Translational Science Awards (CTSAs) and more than 100 Chinese clinical and translational centers. As a gathering of diverse stakeholders, the symposia have provided a forum for developing a vision and a network to carry out the mission of clinical and translational science among the biomedical research and health care communities of the United States, China, and other countries. Goals include the implementation of cross-cultural education and training programs, development of networks for organizing patient-oriented consortia, creation of platforms for defning specifc health care problems to be solved, cultivation of resources for sharing collaboration tools, and wide adoption of best practices regarding human research protections, biobanks, and ethical translational research. Implementation of these goals should result in better outcomes for patients around the world.
Downloaded from http://stm.sciencemag.org/ on November 14, 2015
Kerong Dai is Director and Professor at Bone and Joint Research Center, Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Joining forces to drive biomedical translation
KEY AREAS FOR FUTURE FOCUS Te scientifc advisory committee of the Sino-American symposium comprises translational research experts and executive members who share common interests in promoting international partnerships. Committee members are well represented across U.S. and Chinese academic institutions, teaching hospitals, regulatory agencies, nonproft organizations, and industry. To nurture further fruitful collaborations between the U.S. and Chinese translational science communities, the scientifc advisory committee has drafed a new 5-year strategic plan (for 2014 to 2019) and is eager to share it publicly and invite comment from the scientifc and policy communities in both countries. As the recent Institute of Medicine report on the CTSA program noted (1), community engagement is a fundamental pillar for creating a full spectrum of translational research activities, and this area needs further exploration in the context of our international platform. Highlights of the draf strategic plan are summarized in the following sections. Education and training programs. For implementation of education and training programs, the primary driving forces and leadership organizations are the Association for Clinical and Translational Science, the CTSA consortium of education and training programs in the United States, and the Chinese Medical Association and Chinese International Medical Exchange Foundation in China. For establishing unifed scientifc disciplines and quality standards in translational research, a measurable and executable goal is to develop shared curricula and to catalog expertise in training and education. Because of the vastly diferent clinical, therapeutic, and medical education environments across the two countries, best practices for training include problem-based study strategies—for example, in the United States, focusing on translation of discoveries and better patient outcomes from bench to the bedside, while in China focusing on challenges of moving therapeutic questions back to the laboratory for further research. A prime solution for disseminating advanced knowledge and informatics would be to develop online courses, smart phone–based applications, and focus-group webinars that provide active platforms for engaging new generations of physician-scientists. Te long-term goal for education and training collaborations is to enable U.S. and Chinese universities and health institutes to pursue joint education programs for advanced degrees in clinical and translational science. Collaboration models for research projects. In current models of collaboration and communication in health care–related translational research, the key stakeholder communities are academia, industry, and regulators. Te goal is to reduce the barriers in communications across these three groups and to share visions and expertise among the investigators and decision-makers from each of the groups. In the draf strategic plan to guide Sino-American collaboration, we propose an “NPR” model—that is, one of integrated networks, platforms, www.ScienceTranslationalMedicine.org 18 February 2015 Vol 7 Issue 275 275ed1
1
EDITORIAL
Downloaded from http://stm.sciencemag.org/ on November 14, 2015
and resources—to facilitate interactions among national and international scientifc communities. To determine how the NPR model can beneft specifc collaborations, each party’s interests and priorities must be fairly and clearly delineated. Terefore, the plan needs networks to efectively organize patient-oriented consortia and focus groups. Such a concept also needs platforms to clearly defne specifc interests in human diseases and problems to be resolved. It also needs resources for sharing innovative tools and solutions to enable high-quality collaborative work, to validate the efectiveness and efciency of collaboration products, and to facilitate community engagement across countries. Science frst: Sharing standards and best practices. To promote “science frst” as a guiding principle for translational research collaborations, all parties must adopt best practices—for example, regarding biobanks, such as the guidelines prepared by the International Society for Biological and Environmental Repositories (2)—and establish a joint biobank-qualitymanagement accreditation program. All parties must also discuss the critical path from discovering biomarkers to regulatory reviewing standards as described by the Biomarker Qualifcation Program (www.fda.gov/drugs/developmentapprovalprocess/drugdevelopmenttoolsqualifcationprogram/ucm284076.htm), which was developed jointly by the U.S. Food and Drug Administration and other international regulatory agencies. Te strategic plan also asks for the development and implementation of best-practice models for addressing needs in bioinformatics, intellectual property rights, and technology transfer agreements across international borders. Regulatory science, bioethics, and research-participant protections. Te draf strategic plan also addresses the shared responsibilities to harmonize regulatory sciences across both countries and to understand the unique regulatory policies applied by individual countries. Furthermore, in alignment with the trends of globalization in clinical and translational science, it will be necessary to address how to catalyze investigator-initiated translational research as a proof of concept, to fnd ways to advance industry-sponsored translational research as a model for bringing innovations to the market, and to identify efective and effcient solutions to fll in gaps in care delivery to improve health care quality. An accreditation program for human research protection established by the nonproft Association for the Accreditation of Human Research Protection Programs, Inc., has been introduced in Chinese research enterprises and in hospital-based clinical and translational research centers. Tis program could provide templates for developing regional standards and best practices in cooperation with human research protection standards and bioethics guidelines. Tus, building common ethical standards along with translational research practice would be one of the greatest challenges faced by all parties, but it must be completed well in advance of initiating large-scale collaborations. By 2019, we envision that the Sino-American symposium consortia will be maturing as an international clinical and translational science research community under the NPR model. Meanwhile, more internationally oriented physician-scientists will be trained and will have participated in Sino-American collaborations. It is our collective responsibility to formalize human research protection standards to create an improved translational research environment globally and to share scientifc standards and best practices across international borders. Tim Z. Shi, Hong Liang, Xiaokun Liang, Qimin Zhan, Kerong Dai, Barbara M. Alving, Depei Liu, Jianping Dai, Anantha Shekhar, Xiaobing Fu
SUPPLEMENTARY MATERIALS www.sciencetranslationalmedicine.org/cgi/content/full/7/275/275ed1/DC1 Table S1. Bilateral partnerships between the U.S. and Chinese academic institutions to promote clinical and translational sciences.
1. U.S. Institute of Medicine, The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research (National Academies Press, Washington, DC, 2013); www.nap.edu/catalog.php?record_id=18323&utm_expid=44180425.krRTDpXJQISoXLpdo-1Ynw.0. [A Chinese edition, published by Science Press and carrying the ISBN 978-7030408051, is available from www.amazon.com/Translational-Research-Exploration-Medicine-Chinese/dp/7030408055.] 2. International Society for Biological and Environmental Repositories, 2012 best practices for repositories: Collection, storage, retrieval, and distribution of biological materials for research. Biopreserv. Biobank 10, 79–161 (2012). ACKNOWLEDGMENT: We thank K. O’Moore-Klopf (East Setauket, NY, USA) for professional English-language editing of this article.
www.ScienceTranslationalMedicine.org 18 February 2015 Vol 7 Issue 275 275ed1
2
Joining forces to drive biomedical translation Tim Z. Shi, Hong Liang, Xiaokun Liang, Qimin Zhan, Kerong Dai, Barbara M. Alving, Depei Liu, Jianping Dai, Anantha Shekhar and Xiaobing Fu (February 18, 2015) Science Translational Medicine 7 (275), 275ed1. [doi: 10.1126/scitranslmed.aaa2363] Editor's Summary
Article Tools
Visit the online version of this article to access the personalization and article tools: http://stm.sciencemag.org/content/7/275/275ed1
Supplemental Materials
"Supplementary Materials" http://stm.sciencemag.org/content/suppl/2015/02/17/7.275.275ed1.DC1
Related Content
Permissions
The editors suggest related resources on Science's sites: http://stm.sciencemag.org/content/scitransmed/5/196/196ed11.full http://stm.sciencemag.org/content/scitransmed/4/122/122cm3.full http://stm.sciencemag.org/content/scitransmed/6/242/242cm6.full http://stm.sciencemag.org/content/scitransmed/2/52/52cm26.full http://stm.sciencemag.org/content/scitransmed/5/200/200fs35.full http://stm.sciencemag.org/content/scitransmed/7/281/281fs13.full Obtain information about reproducing this article: http://www.sciencemag.org/about/permissions.dtl
Science Translational Medicine (print ISSN 1946-6234; online ISSN 1946-6242) is published weekly, except the last week in December, by the American Association for the Advancement of Science, 1200 New York Avenue, NW, Washington, DC 20005. Copyright 2015 by the American Association for the Advancement of Science; all rights reserved. The title Science Translational Medicine is a registered trademark of AAAS.
Downloaded from http://stm.sciencemag.org/ on November 14, 2015
The following resources related to this article are available online at http://stm.sciencemag.org. This information is current as of November 14, 2015.
